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Six samples of various thicknessess of Gore-Tex compounds were fashioned into trileaflet valves. A radiopaque marker was placed on the center of the free margin of each cusp, and the prostheses were implanted in the tricuspid position of dogs. Two Hancock valves were studied for comparison. Catheterization revealed that the hemodynamic function was normal in all valves tested. High-speed radiography permitted analysis of leaflet movement throughout the cardiac cycle. Of the six Gore-Tex valves, five opened completely. The cusps of these five valves were fabricated from 4, 6, 8, 10, and 12 layers of Gore-Tex film. The remaining valve, which was fabricated from 15 layers of Gore-Tex film, and both porcine xenograft aortic valves did not open completely. We postulate that the laminates of 12 layers or less of Gore-Tex film are suitable for further study to evaluate their potential applicability in trileaflet cardiac valve prostheses.

Radiographic assessment of leaflet motion of Gore-Tex laminate trileaflet valves and Hancock xenograft in tricuspid position of dogs.